“An experiment is ethical or not at its inception, it does not become ethical post hoc – ends do not justify means. There is no ethical distinction between ends and means.”

-- Henry K. Beecher, MD

New Engl J Med 274(24) June 16, 1966 pp 1354-1360.

"When everything is digitalized, all your records - your privacy is protected, but all your records on a digital form - that reduces medical errors. It means that nurses don't have to read the scrawl of doctors when they are trying to figure out what treatments to apply. That saves lives; that saves money; and it will still ensure privacy."

The implementation of the electronic medical record (EMR) in American medicine gained a powerful foothold in medical care with the passage of the American Reinvestment and Recovery Act (ARRA) in 2009. With the passage of this act came the promise of improved efficiencies, safety and ultimately reduced cost delivery for health care. Also, some $18 billion dollars in financial incentives were offered to physicians to offset costs to deploy these systems nationwide. To assure adoption, if the systems were not implemented by 2015, doctors and care providers will suffer payment penalties from the government. For physicians who care for Medicare patients, there was no alternative than to deploy these systems.

In 2010 alone, the EMR market was pegged at $15.7 billion dollars, a cost that is ultimately passed to all Americans. In addition, despite all of the changes that health care reform has brought to date, people in some states continue to see their insurance premiums mushroom over 20% in 2013 from the preceding year. Simply put, patients are finding health care anything but “affordable.”

We should acknowledge that there might be cause, ethically, to deploy a technology that truly benefits patients at some cost. After all, you have to break a few eggs to make a good omelet. If interoperability of EMR systems between facilities were commonplace and clinical data were shared with ease while patient privacy was vigorously upheld flawlessly, the cost of these systems might be ethically justified.

But the promise of improved efficiencies to our health care system, improved patient safety and (especially) reduced cost for our health care system remain elusive. More importantly these goals remain unproven. In fact, examples that the opposite is occurring abounds as doctors struggle to enter ever-increasing amounts of information of no relevance to the patient’s presenting problem just to prove they’re using the EMR in a “meaningful” way, health data security breeches continue, errors are growing instead of shrinking, data-mining of patient information is occurring not just for patient care but for marketing purposes, and the direct costs of health care for patients continues to rise, not fall. Proponents of these systems will argue these issues are nothing more than “growing pains” of these novel systems.

So should we step back for a moment and ask ourselves if we are being ethical to patients with the deployment of this technology? Does the ends of presumed cost savings to our national health care system justify the deployment of poorly integrated, difficult-to-use systems? Are patients being subjected to new risks heretofore never considered with the adoption of this technology? Could a tiny programming error occur that negatively impacts not just one patient, but millions? If so, what are the safeguards in place to prevent catastrophic error? Who will be responsible? Who is the oversight body that assures the guiding principles of the Belmont Report (respect for persons, beneficence and justice) with respect to EMR deployment are followed? The Secretary of the Department of Health and Human Services or a more nebulous body like Congress?

If we accept that the benefits of the EMR are at least uncertain to patients in terms of risk and cost, we should demand they be studied before deploying them. The guiding medical ethics tenets would demand nothing less. So, would not such study qualify as human research? After all, we should remember that the United States and other countries have a precedent of human research programs performed by government agencies that were usually highly secretive, and in many cases information about them was not released until many years after the studies had been performed.

"I should like to affirm that American medicine is sound, and most progress in it soundly attained. There is, however, a reason for concern in certain areas, and I believe the type of activities to be mentioned will do great harm to medicine unless soon corrected. It will certainly be charged that a mention of these matters does a disservice to medicine, but not one so great, I believe, as a continuation of the practices cited.

Experimentation in man takes place is several areas: in self-experimentation; in patient volunteers and normal subjects; in therapy; and in the different areas of experimentation on a patient not for his benefit but for that, at least in theory, of patients in general."

While Beecher’s paper was addressing ethical research errors in general, his words are oddly prescient for EMR development. Ethical errors, as he pointed out, “are increasing not only in numbers but in variety.” He points to one of the biggest drivers of ethical conflict: money.

“Of transcendent importance is the enormous and continuing increasing in available dollars for research, as shown below:

Money Available for Research Each Year

Year

Massachusetts General Hospital

National Institutes of Health

1945

$500,000

$701,800

1955

2,222,816

36,063,200

1965

8,384,342

436,600,000

These data, rough as they are, illustrate vast opportunities and concomitantly expanded responsibilities.

Taking into account the sound and increasing emphasis of recent years that experimentation in man must precede general application of new procedures in therapy, plus the great sums of money available, there is reason to fear that these requirements and resources may be greater than the supply of responsible investigators.”

The need for “responsible investigators” remains significant; funding for all of the National institute of Health in 2011 was $142.5 billion dollars. Annually, EMR companies have received the equivalent of 11% of the entire NIH annual research budget from US citizens without having to prove their safety or value to patients.

Again, from Beecher’s paper:

“The ethical approach to experimentation in man has several components; two are more important than others, the first being informed consent. The difficulty of obtaining this is discussed in detail. But it is absolutely essential to strive for it for moral, sociologic, and legal reasons. The statement that consent has been obtained has little meaning unless the subject or his guardian is capable of understanding what is to be undertaken and unless all hazards are clear. If these are not known this, too, shall be stated. In such a situation the subject at least knows that he is to be a participant in an experiment. Secondly, there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.”

Because EMR deployments are cloaked in intellectual property, non-disclosure and restrictive hospital employment agreements, doctors are often prohibited from voicing specific concerns about an EMR system publicly. In addition, by adopting EMR systems as cornerstones of the American health care system, Congress, the President and the ARRA side-stepped patients’ informed consent regarding the short-comings of these systems, advertising only their desired benefits instead. Furthermore, rather than Congress turning to “conscientious, compassionate, responsible investigators,” they turned to lobbyists when deciding to fund the deployment of unproven EMR systems. As a result, doctors were relegated to becoming nothing more than stewards of data entry subject to new, ever-evolving documentation requirements as these systems evolve for cost-saving benefits and care "efficiencies."

Patients and doctors alike understand the need for improved efficiencies and value in our era of exploding health care costs. We must strive to find a solution to our health care cost crisis that is transparent, cost-effective and ethical. Without such an effort, our health care system will collapse. Only recently has the Office of the National Coordinator of Health Information Technology recognized the problem and opened their Health IT Patient Safety Action and Surveillance Plan for public comment. This plan asks the EMR companies and interested stakeholders to develop their own methods to assure patient safety and reporting systems – a move that approaches the same ethical standards as equivalent of asking the foxes to watch the henhouse. Nonetheless, we should acknowledge their efforts.

But we should be cautious of EMR systems as we move forward. After all, these clinical systems have not been subjected to the same cost-benefit and ethical scrutiny as other clinical tools we use in health care. The scrutiny of EMRs should be no different than that found with pharmaceutical or medical device research where Institutional Research Board approval and proof of no conflict of interest is demanded. Why should clinical EMR systems be any different?

Given the profit motives and market consolidation occurring amongst the purveyors of these EMR systems and the potential for lethal EMR errors both from software and human interface issues, doctors and patients must especially question the ethics of the movement to deploy untested, novel technology on our patient population under restrictive covenants. As part of informed consent, patients should have full understanding of how and where their clinical data are used, including when it will be used for direct-marketing campaigns, prioritizing care delivery, or for research. Patients should be able to opt out of the use of their clinical data for these or any other purpose if desired, without restricting payment for care. Finally, physician and patient concerns about EMR systems should be allowed to be vetted publicly and without threat of professional or personal reprisal or the withholding of payments for care rendered, especially and particularly if these disclosures are performed in the best interest of patient care.

To do otherwise is unethical for our patients and the public at large.

7 comments:

EMRs should be built by docs
said...

I agree, patient safety should not be compromised. I believe, however, there needs to be a change to our language and semantics of this debate -- criticizing EMRs as a concept makes no sense. If implemented right they should INCREASE our patients safety. Our 'top' vendors ae delivering a subpar product and we are too swept up in the debate to support real growth and improvement in what they ae delivering us. Let's be specific about which EMRs are giving us a headache so we can fix them or build new ones that don't.

It is virtually impossible for physicians snd end-users of these systems to be "specific about which EMRs are giving us a headache" when (1) they are prevented from posting screenshots or clear examples online by restrictive covenants and (2) will never have an opporuntity to evaluate systems side-by-side before deployment because of our nation's rush to implement these systems. More concerning, however, is that many hospital systems were either "penny wise and pound foolish" in their purchase due to cost concerns or enjoying "incentives" provided by EMR vendors in return for purchasing their system. These unethical and covert practices were widespread in the industry and remain problematic. Furthermore, other conflicts exist when many of the CEOs of the largest EMR vendors serve as consultants to the Office of the National Coordinator for Health IT (ONC).

Ethics..what a quaint, obsolete word. The list of justifications given for the rampant cheating I observed as an educator was extensive.These were the " elite" of the secondary school system..future docs, lawyers, and engineers. One study of cheating in graduate school was conducted which included the interesting anecdote: Do you believe that cheating per se is wrong? yes. Would you cheat on a research project/lab etc. to ensure a grade or a desired experiment outcome? yes. When do you anticipate you will not cheat? When I get a job after completion of my studies. Unfortunately, the habit of deceit will have long since taken root.

Now that we're years down the HITECH road, it seems way too late to begin thinking about ways to evaluate whether the implementation and use of EHRs could have unintended consequences and how we should prevent harm to patients (and users) from them.

Expecting, identifying and addressing unintended consequences should have been built into the HITECH program from the start. But, of course, it wasn't.

It is fanciful to expect ONC to work against the goals and metrics of its own program to address this at this stage of the game.

Can anyone imagine widely adopted systems being pulled off of the market (i.e. not certified) and providers who have implemented them and received MU checks for them needing to replace them?

The very large, very famous medical center in our city spent a year and about $500,000 customizing the Ophthalmology module of the ubiquitous Epic system. When asked when the rest of us would be able to use this breakthrough development, or at least when we might see this in the other academic departments around the country who have been bedeviled by Epic the answer was:"Never. We will keep it for ourselves. Our deal let's us have it exclusively."

Nice...even a potential solution to the issues raised falls prey to a market.

EMR's are hardly experimental as a clinical application. Many have existed for over 30 years. Providers feel rushed by ARRA because there is now a financial carrot that turns into a stick. I don't think you can honestly argue that computers and software operate with any larger degree of danger in healthcare than in any other industry. EMR's are no less proprietary than medical device manufactures. They don't openly post their code any more than Epic or McKesson.

How would you propose evaluating EMR's side by side? Every hospital demands the ability to customize and change the EMR so it operates how the facility chooses. All EMR vendors allow you observe an operational facility or speak to actual users.

You don't address how dangerous, unsafe, and costly a paper record is so how can you compare an EMR to any alternative? As a patient, I have no confidence in med administration without an electronic closed loop process.

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.